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Combinations of products for the convenience and personal protection of the end user from blood, body fluids and chemicals while conducting specific procedures. The kits will include disposable, single use items for blood, drug or chemical spill clean up, drug preparation and/or drug administration.

Procedure Specific kits are non-sterile kits that bundle or package together combinations of products for the convenience of the user. This saves the end user the time and effort of retrieving the individual products each time a procedure is performed. Kit components are purchased as released finished goods in finished package form. To assemble a kit, individual products are selected, sealed in a polybag or other suitable container, and labeled with a contents label. If the finished package form is more than one unit, Sage will remove the number of units specified for the kit being assembled. The item will be repackaged in the kit without compromising the integrity of the product. There is no reprocessing of any of the components that would compromise an original intended use or alter its safety or effectiveness.

This document is a 510(k) Summary for "Procedure Specific Kits" from Sage Products Inc., dated February 14, 1997. It describes convenience kits that bundle various products for specific medical procedures.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets acceptance criteria in the manner requested (i.e., performance metrics, sample sizes, expert ground truth, etc.).

The document focuses on the description of the device as non-sterile convenience kits, the process of assembling them, and their substantial equivalence to predicate devices under the pre-market notification process.

Here's why the requested information cannot be provided from this text:

• Type of Device: The "device" in question is a "convenience kit" or a "procedure specific kit." These are essentially repackaged collections of existing, cleared or pre-amendment medical devices. The document explicitly states: "There is no reprocessing of any of the components that would compromise an original intended use or alter its safety or effectiveness."
• Regulatory Pathway: The submission is a 510(k) pre-market notification, which seeks to demonstrate substantial equivalence to a predicate device. It is not a submission for a novel, high-risk device requiring extensive clinical trials or performance studies with the detailed metrics you've asked for.
• Focus of the Document: The content emphasizes that the individual components bundled in the kits are already cleared or exempt devices, and the packaging of these components does not affect their safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, expert involvement, or AI performance because the provided document does not contain this type of information. It falls outside the scope of this particular 510(k) submission, which is more about administrative bundling of pre-existing, cleared components rather than demonstrating novel device performance.

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